BSMS > Research > Support and governance > Working with human tissue

Working with human tissue

The Human Tissue Authority (HTA) was set up to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes – such as research, transplantation, and education and training – set out in the Human Tissue Act 2004 (HT Act).

The HT Act covers England, Wales and Northern Ireland and came into force on 1 September 2006.

BSMS, under the aegis of the University of Sussex, currently holds two licences – one anatomy licence and one research licence – which cover the storage of human tissue for purposes under the act.

The University of Sussex HTA management policy is to ensure compliance with the HT Act and with the standards and guidance set by the HTA. The level of quality required is achieved through the adoption of a system of procedures that reflect the regulatory standards and guidelines.

Quality Management System

All staff who work with human tissue are involved in achieving compliance with these procedures and are individually responsible for the quality of their work.

The Designated Individual retains responsibility for the Quality Management System with routine operation controlled by the individual Principal Investigator or Person Designate.

The objectives of the Quality Management System are to:

maintain an effective Quality System complying with the Human Tissue Act and the standards and guidance issued by the Human Tissue Authority
ensure compliance with relevant statutory and safety requirements
achieve and maintain a level of quality that enhances the university's reputation with stakeholders
protect the rights and interests of the donors

It is important that all human tissue is processed in designated laboratory areas only by fully trained personnel. Researchers who will be processing and storing human tissue and who do not have designated laboratory facilities should contact J.Kneller@bsms.ac.uk.

Anatomy licence

BSMS is a member of the London and South East Committee of Anatomists, of which the public face is The London Anatomy Office – established in the early 1980s to provide a central service for coordinating the donation of bodies to the London medical and dental schools.

Over 6,000 generous and public-spirited people are currently registered with the London Anatomy Office to donate their body. Each year, approximately 300 donated bodies are accepted by the London Anatomy Office on behalf of numerous intuitions.

BSMS is licenced to hold and undertake teaching and research from donated individuals.

BSMS Research licence

The main purpose of the HTA research licence is to allow us to store human tissue for extended periods of time in order to use it for current and possibly future research.

A licence is required in the following circumstances:

Once the Ethical approval from an NRES approved project has expired (material stored under valid NRES approval does not require an HTA licence)
If you want to store and use material from healthy volunteers (your project will require review and approval by an internal ethics committee only)
If material has been imported from elsewhere (another UK institute, a Biobank or an international location)

Notification to the BSMS Tissue Governance Manager (HTA@bsms.ac.uk) is required for points 2 and 3 above and for point 1 when the PI intends to store material after the completion of the NRES-approved project (ie he or she wants to store for future unspecified research).

The requirements for storage under the BSMS HTA research licence are:

All samples must be logged into FreezerPro (the dedicated, shared HTA sample database); please contact HTA@bsms.ac.uk for guidance
Consent for the samples to be used in future projects (other than the current one) must include ‘Future unspecified research’ or similar
New project approval must be sought from the appropriate ethics committee prior to start of further work

BSMS Tissue Bank

BSMS does not currently have a dedicated Biobank where material is acquired specifically for this purpose.

However, PIs are welcome to build-up their own tissue collections through any of the routes described above (1, 2, and 3). This form of Biobanking is then essentially the storing of material acquired through a research study for a future project(s) and so PIs need to ensure that the correct consent (for future unspecified research) is obtained when the sample is collected.

Download a summary of the BSMS HTA licence >

Please see the University of Sussex's Life Sciences HTA web pages for further information.

Those conducting clinical trials may wish to make use of the Clinical Trials Unit.

BACKGROUND IMAGE FOR PANEL

Materials Transfer Agreement

The University of Sussex and the University Hospitals Sussex NHS Foundation Trust have agreed the wording of a template materials transfer agreement (MTA).

This provides a framework for all BSMS researchers who wish to engage in research using clinical material in collaboration with colleagues at University Hospitals Sussex NHS Foundation Trust. The hope is that this standard MTA will promote research between the two organisations and expedite the institutional and HRA approvals process.

Simply download the form below and add the details of your study to the Schedule section of the form prior to submission for University sponsorship to the University Sponsorship Sub-Committee or to the BSMS Research Governance and Ethics Committee (RGEC).

If you have any enquiries about the MTA, please contact Professor Chris Pepper.

Download the Materials Transfer Agreement >